Providers are now faced with conflicting interpretations of The Patient Safety Rule—the May 24 sub-regulatory guidance by HHS conflicts with legal opinions issued by organizations representing many health care providers (e.g., Joint Commission, AHA). The US Supreme Court may take up a case to resolve this conflict. We should know by the end of June as to whether the Court will act. In the meantime, providers should carefully consider how to address requests for information that is considered Patient Safety Work Product (PSWP) and consider whether their current PSES needs to be reviewed and modified in response to the guidance.
New guidance by HHS removes PSWP privilege from records produced by the provider that have more than one purpose. Now, PSWP would apply only to records produced solely for reporting to the PSO. The word ‘solely’ was never used previously in relation to PSWP in either regulation or law. Even if this interpretation holds, it does not affect PSWP protection of the copies of such records shared with the PSO (unless the provider destroys the original record, leaving the PSO with the only extant copy).
Scenarios from HHS
The following three scenarios represent the HHS guidance as to how PSWP privilege applies, “where a provider maintains specific forms regarding adverse events in order to satisfy a federal or state law obligation.”— 81 FR 32658, May 24, 2016. Note that scenario two is the one most commonly used by providers across the USA, and, if the HHS interpretation is upheld by the courts, this workflow would be prohibited; providers would have to use the workflow in scenario one instead. The analysis would be different for a provider that is not required by law to collect safety-related reports (e.g., incident reports).
The provider maintains the original forms outside of the PSES [Patient Safety Evaluation System] and places duplicate copies in the PSES for reporting to the PSO, so that further analysis using information in the forms can be conducted: The forms outside of the PSES are not PSWP, for the reasons indicated above. The copies in the PSES would be PSWP, provided that: (1) The information otherwise meets the definition of PSWP and (2) the original forms continue to be maintained by the provider outside of the PSES. If, while the provider is required to maintain the forms, the forms outside of the PSES become unavailable (e.g., they are lost or destroyed), the duplicate copies of the forms in the provider’s PSES will be “original provider records” that are no longer privileged and confidential PSWP so long as no duplicate copies of the forms are maintained outside of the PSES by the provider.
The provider only maintains the original forms in the PSES: The forms are original provider records and not privileged and confidential PSWP. We note that it would be improper to maintain records collected for external reporting purposes solely within a PSES because this scenario would be a misuse of a PSES.
The provider maintains the forms outside of the PSES and within the PSES extracts information from the forms to conduct further analysis: The forms outside of the PSES are not PSWP, for the reasons indicated above. The analysis conducted inside the PSES, including the information extracted from the forms, is PSWP.
As many of you know, we have been following a petition to the US Supreme Court regarding a Kentucky Supreme Court case (Tibbs v. Bunnell). The petitioners requested the Court to reverse, arguing that records that must be collected and maintained but not reported pursuant to state law can be collected in a provider’s PSES for reporting to a PSO, and therefore qualify as PSWP.
The petitioners filed for review March 18, 2015. On October 5, the Supreme Court invited the US Solicitor General to submit a brief. This is a common request when the Supreme Court wants an opinion as to whether a specific case merits the Court’s attention.
On May 24, 2016, HHS issued sub-regulatory guidance regarding PSWP and providers’ external obligations. The guidance represents the department’s interpretation and intends to clarify existing law, as the government cannot change the patient safety rule without promulgating a new regulation through the formal rule-making process. On that same day, the Solicitor General (SG) filed his brief, relying in part on the HHS guidance, telling the court that it does not need to grant the petition for certiorari because there is no issue to be resolved as it is HHS’s view that “any information that is prepared to meet any Federal, state, or local health oversight agency requirements is not [patient safety work product].” In HHS’s guidance, the definition of “original provider records” now includes records that a provider is required to maintain under law—this is contrary to many others’ interpretation of the law and rule. HHS states:
“HHS reiterates that any external reporting or recordkeeping obligations— whether they require a provider to report certain information, maintain specific records, or operate a separate system—cannot be met with PSWP. We also clarify that any information that is prepared to meet any Federal, state, or local health oversight agency requirements is not PSWP. As discussed above, the Patient Safety Act was intended to spur the development of additional information created through voluntary patient safety activities and to provide privilege and confidentiality protections for such new information. It was not intended to protect records generated or maintained as part of providers’ existing mandatory information collection activities.” – 81 FR 32657, May 24, 2016.
HHS also states that, to have the potential to be PSWP, the information cannot be collected for another purpose (e.g., risk management) and must be prepared solely for reporting to a PSO, even though solely is not found in the Act or Final Rule. The guidance takes a stance regarding PSWP at odds with our industry as reflected in the petitioner’s brief and supported by the amicus curiae briefs of the AHA, of the Joint Commission, and of many PSOs (including CHPSO). The petitioners submitted a supplemental brief on June 6 in response to the SG’s brief and the HHS new guidance opening with the following harsh language:
“In the guise of ‘clarifying’ the patient-safety work product privilege, the Department of Health and Human Services rewrote it to exclude material protected by the rule HHS purported to interpret. This made-for-litigation ‘guidance’ deserves no deference, and only heightens the need for this Court’s review.”
The above statement highlights the current quandary—sub-regulatory guidance by HHS directly conflicts with legal opinions issued by organizations representing many health care providers and PSOs. We believe that, until this conflict is resolved, providers should consult counsel regarding any requests for documents they believe to be PSWP and consider whether their current PSES needs to be reviewed and modified in response to the guidance. The documents attached to this article (the Supreme Court briefs and the new guidance) should be of assistance. It is unclear how courts will view the new guidance, though they tend to defer to a governmental guidance unless it is strongly challenged.